March 15 (Bloomberg) -- Eli Lilly & Co., the maker of the impotence pill Cialis, acquired from Acrux Limited a license to commercialize an underarm testosterone lotion for men whose low levels of the hormone leave them with limited sex drive.

Indianapolis-based Lilly will pay Acrux of West Melbourne, Australia, a $50 million license fee plus $3 million when manufacturing assets are transferred, the companies said today in a statement. Acrux may earn $87 million more if U.S. regulators approve the drug for marketing, $195 million in commercial milestone payments as well as royalty payments on future sales, the companies said.

More than a third of American men older than 45 show reduced levels of testosterone, U.S. researchers found in a 2006 study. It can sap sex drive and cause impotence, osteoporosis and memory loss, according to the Mayo Clinic in Rochester, Minnesota. Results of a clinical trial released in September showed Acrux’s lotion, called Axiron, brought testosterone levels to normal in 84 percent of men after four months.

“The addition of Axiron reinforces Lilly’s commitment to men’s health and, if approved, could provide a new treatment option for men suffering from low testosterone,” said Bryce Carmine, president of Lilly’s Bio-Medicines.

Acrux, which has never made a profit, rose 9 cents, or 3.9 percent, to A$2.38 in trading on the Australian stock exchange before the licensing deal was announced. The shares have more than tripled in the past year.

actually there are oral forms for testosterone..too many issues with roll ons and orals...axiron will be a great product and theres already alot of talk with physicians who r excited for it to come out..and managers are in the interview hiring process for reps to sell axiron.... reps will promote axiron,cialas. and cymbalta

Another blunder brought to you by the FIPNET strategy. Empowered Heroic BU leadership (DR) making decisions to give hundreds of millions away to another company that can't deliver. Lilly is so desperate that it gives millions away to other companies while it cuts people, salary, merit, and bonus for the people who have the knowledge and know how to save the company. All the while giving a huge bonus to the management that is "saving" the company. What a strategy.

A new study that finds low testosterone is much less common in older men than previously thought - and is closely identified with just nine specific symptoms - may cause physicians and patients to rethink their use of various elixirs. Take AndroGel, for instance. The salve is cleverly promoted on an unbranded web site called ‘Is It Low T?,’ which features a quiz. The site lists various symptoms and risks purported to be associated with the condition, although some do not match what was noted in the study, which was published last week in The New England Journal of Medicine.

The study found that only 2 percent of men aged 40 to 80 suffer from the condition, which is also called male menopause, andropause or late-onset hypogonadism. The researchers measured testosterone levels in 3,369 men between those ages and then correlated their levels with different symptoms. Of 32 possible symptoms, only nine were linked with decreased testosterone. Three were physical - unable to engage in strenuous activity, walk about a mile or to bend over or kneel - and three were psychological — low energy, sadness and fatigue. However, these six symptoms were only mildly linked to the problem, while three sexual symptoms - less frequent morning erections, low sex drive and erectile dysfunction - were closely related to low testosterone.

“Our results also highlight the substantial overlap between late-onset hypogonadism and non-specific symptoms of aging. The application of these new criteria can guard against the excessive diagnosis of hypogonadism and curb the injudicious use of testosterone therapy in older men,” conclude the researchers, who noted the condition is usually associated with advancing age, yet there is little evidence about the “exact criteria for identifying testosterone deficiency in older men.”

Meanwhile, Abbott’s Solvay Pharmaceuticals unit actively promotes on its site that low testosterone affects more than 13 million men in the US over the age of 45. An Abbott spokesman points to a pair of studies used to bolster the notion that low testosterone will increase substantially with age, including in men well past 65 years old, although these were published in 2004 and 2007 (look here and here). Yet the AndroGel prescribing info acknowledges there haven’t been enough men 65 and older who have participated in clinical trials to know whether the treatment is safe or effective. And it is now 2010. Of course, now that the NEJM study dismisses the notion that older men are more likely to develop the problem, Solvay may not have to conduct a study.

The Low T site also states that the risk of developing low testosterone is 2.4 times greater if one is obese; 2.1 times greater if is one has diabetes; 1.8 greater with high blood pressure and a 1.5 higher risk if one also has high cholesterol. The evidence for this claim comes from this 2006 study. These may be accurate, although for the record, all five authors had ties to Solvay (click on authors and disclosures in the link to the study). Similarly, six of the seven authors of the Endocrine Society Clinical Guidelines for treating low testosterone have ties to Abbott (see page 31). This may confuse some people, since the ‘Low T’ site is identified as a Solvay site. However, a summary of the older version of the guidelines lists financial ties to Solvay (see this).

Also interesting is the pop quiz….

To gauge its usefulness, we deliberately answered ‘no’ to each of the 10 questions, which asked about whether we had lost our libido, energy, strength, height, enjoyment of life, and a few other choice topics. In other words, we deliberately avoided offering any indication that a problem may exist. Just the same, we received this reply: “Your answers show that you have a lower risk for low testosterone (Low T). But it’s still important to talk with your doctor about your symptoms. They may be caused by treatable condition.” What symptoms? Hard to say. Unless one is being pushed to ask a doctor for something.

In response to questions, the spokesman tells us that the site is “designed to simply raise awareness about the condition so that men who believe they’re suffering from the problem can have a conversation with their doctor about it…The quiz is not a diagnostic tool, but is a trigger to have that dialogue with the physician. Someone who takes the quiz may be feeling something isn’t right, so this says that perhaps they should still explore that. But it’s not intended to be diagnostic.”

And what about the site? Will Solvay modify it to reflect the findings from the NEJM study? “We believe there’s plenty of data that would suggest there’s a constellation of symptoms that may be associated with Low T,” he says. “We certainly always encourage continued scientific discovery and continue to look at this, but we still feel sufficient data out there that suggests this whole array of symptoms maybe associated with Low T.”

Another huge waste of stockholder money. Testosterone deficiency in about 2% of men. I would hazard to guess that much of that may be due to chronic alcoholism.

Click to expand...

But the off label opportunities increase it to 100% of men! Longer unit, more girth, more stamina, staying power, deeper voice for singing in the church choir, increased muscle mass, six pack abs and emission of an animal musk allure that will attract all women within a 12 foot radius (more if down wind!)! Think of the Infomercial "opportunities". Hire a few porn stars to swear to the other benefits and Lilly is on it's way to another blockbuster!

But the off label opportunities increase it to 100% of men! Longer unit, more girth, more stamina, staying power, deeper voice for singing in the church choir, increased muscle mass, six pack abs and emission of an animal musk allure that will attract all women within a 12 foot radius (more if down wind!)! Think of the Infomercial "opportunities". Hire a few porn stars to swear to the other benefits and Lilly is on it's way to another blockbuster!

Click to expand...

Hmmm. I would buy some. Some good benefits / side effects. Especially the deeper voice for church choir.

to all you drug reps who dismiss this, Im a patient who has to use TRT every day & I can tell you we are crying out for a more user friendly form of med! This sounds very promising after having a choice of painful injections that send you on a roller coaster of high then low,
or messy smelly sticky gels that you have to almost cover yourself with - which are too weak ( Androgel) or too sticky (Testim, Tostran)
About time we had some alternatives - might encourage some of your bosses to develop some better products for us! BTW I read its a multi million $ market. Also its very cheap to produce so lots of profits!

Click to expand...

I hope you reside in my territory, and not in the Indy Training Department. I'm quite sure this is going to need all the motivation we can scrounge up.

Good luck with this dog... Nothing new here. I have a hard enough time selling Testim and even worse this freakin' Testopel crap is starting to make its mark and we can't even get data on who is using it. Then we have to compete with these dumbasses who use compounded creams on top of that. Saturated market folks.